Extracorporeal Ultrafiltration (UF) vs. Usual and Customary Care for Patients With Severe Heart Failure (HF)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2009-01-31

Brief Summary

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The purpose of this study is to assess the ability of Ultrafiltration to influence the rate of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion pressure, in patients with NYHA class III/IV Heart Failure.

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Detailed Description

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This study will be preformed in a specialized heart failure unit at the Cleveland Clinic Foundation (CCF) and will include both the UF-treated group and a control group receiving usual and customary care. Patients will be stratified according to renal function at the time of admission. Therapies will be guided by specific hemodynamic criteria routinely used at the study institution.

Conditions

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Heart Failure CHF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrafiltration

Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.

Group Type ACTIVE_COMPARATOR

NxStage System One

Intervention Type DEVICE

Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.

Usual & Customary

Patients treated with conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.

Group Type ACTIVE_COMPARATOR

IV loop diuretic

Intervention Type DRUG

Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.

Interventions

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IV loop diuretic

Use of conventional diuretic therapy upon hospital admission for treatment of decompensated heart failure.

Intervention Type DRUG

NxStage System One

Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Admitted to Heart Failure Unit (H-22) with NYHA class III/IV HF and pulmonary artery catheter in situ
* Left ventricular ejection fraction \<40%
* Mean Pulmonary Artery Occlusion Pressure ≥20 mm Hg
* Able to give informed consent

Exclusion Criteria

* Currently on renal replacement therapy or determined to need renal replacement therapy at the time of enrollment
* Estimated glomerular filtration rate (GFR) \<15 mL/min
* Systolic blood pressure (SBP) \<80 mm Hg
* Acute coronary syndrome
* Hematocrit \>50%
* Malignancy other than prostrate or skin
* Chronic edematous states other than HF, including nephritic syndrome and cirrhosis
* Chronic inflammatory or infectious condition
* Pregnancy
* Previous enrollment in this study
* Expectation of need for heart transplantation or cardiac assist device within one week
* Pulmonary failure requiring intubation and mechanical ventilation
* Known or suspected hypersensitivity to dialysis membranes
* Severe aortic stenosis or regurgitation
* Severe mitral stenosis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No